UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000891 |
|---|---|
| Receipt number | R000001074 |
| Scientific Title | Prospective study of tansarterial embolization for hepatocellular carcinoma with Lipiodol added Lecithin. |
| Date of disclosure of the study information | 2007/11/15 |
| Last modified on | 2007/11/14 20:02:26 |
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Basic information
Public title
Prospective study of tansarterial embolization for hepatocellular carcinoma with Lipiodol added Lecithin.
Acronym
Tansarterial embolization for hepatocellular carcinoma with Lipiodol added Lecithin.
Scientific Title
Prospective study of tansarterial embolization for hepatocellular carcinoma with Lipiodol added Lecithin.
Scientific Title:Acronym
Tansarterial embolization for hepatocellular carcinoma with Lipiodol added Lecithin.
Region
| Japan |
Condition
Condition
hepatocellar carcinoma
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Our objectives are improvement in the treatment of the primary hepatocellular carcinoma and improvement of convalescence of transcatheter arterial embolization, in useing the emulsion which added the lecithin (surfactant in Lipiodol).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
curative effect,response rate,survival time, survival rate
Key secondary outcomes
adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Lecithin Group:We use the emulsion which added the lecithin which is a surfactant in Lipiodol for transcatheter arterial embolization.
Interventions/Control_2
Non-Lecithin Group:We use the Lipiodol which didn't add the lecithin for transcatheter arterial embolization.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1:Histologically proven or clinically diagnosed hepatocellular carcinoma in primary lesion.
2:Age20-85
3:Performance Status0-1(ECOG)
4:Life expectancy at least 3 months.
5:Adequate organ and marrow function listed below.
a.White blood cell(WBC):3,000<=WBC<12,000/uL
b.Absolute neutrophil count(Neu):Neu >=1,800/uL
c.Hemoglobin(Hb): Hb>=8.0g/dL
d.Serum creatinine(Cr):W.N.L
e. Electrocardiogram(ECG):normal
6:Do not become the adaptation of resection,transplant,and local treatment in algorithm of HCC treatment.
7:Without contraindication of TAE.
8:The patient who have given written informed consent to participant in this study.
Key exclusion criteria
1:The patient with the anamnesis of the drug hypersensitivity.
2:The patient with contraindication of medication(Hydrochloric acid doxorubicin, Lipiodol, Gelpert and lecithin).
3:The patient with contraindication of TAE.
a.Severe liver failure
b.Serum Bilirubin(T-Bil):T-Bil>3mg/dl
c.Large quantities of acites.
4:The patient having the activity-related infectious disease(more than fever 38.0 degrees ).
5:The patient having the a serious complication.
6:Pregnant woman.
7: Patients who are judged inappropriate to be enrolled in this study by the doctor in charge.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masakazu Yamamoto |
Organization
Tokyo Women's Medical University
Division name
Department of Surgery, Institute of Gastroenterology
Zip code
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-8111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shun-ichi Ariizumi, Yutaka Takahashi , |
Organization
Tokyo Women's Medical University
Division name
Department of Surgery, Institute of Gastroenterology
Zip code
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-8111
Homepage URL
yutaka@ige.twmu.ac.jp
Sponsor or person
Institute
Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
Women's Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
none
Other related organizations
Co-sponsor
none
Name of secondary funder(s)
none
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2007 | Year | 11 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Date of protocol fixation
| 2007 | Year | 03 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2009 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 11 | Month | 14 | Day |
Last modified on
| 2007 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001074
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